FDA 510(k)

簡易箱分類：CARE多分類CT體

K 號：K252970 · 2026-01-07

決定日期2026-01-07

產品代碼QAS

諮詢委員會RA

決定相當於

器材摘要

BriefCase-Triage: CARE Multi-triage CT Body is the device name listed in this FDA 510(k) record. The listed applicant is Aidoc Medical , Ltd.. It received FDA 510(k) clearance on 2026-01-07 under 510(k) number K252970. The device is classified under product code QAS. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the BriefCase-Triage: CARE Multi-triage CT Body?

BriefCase-Triage: CARE Multi-triage CT Body is a medical device that received FDA 510(k) clearance on 2026-01-07. The listed applicant is Aidoc Medical , Ltd.. The 510(k) number is K252970.

When did BriefCase-Triage: CARE Multi-triage CT Body receive FDA 510(k) clearance?

BriefCase-Triage: CARE Multi-triage CT Body received FDA 510(k) clearance on 2026-01-07, under 510(k) number K252970.

Who is the listed applicant for BriefCase-Triage: CARE Multi-triage CT Body?

The FDA 510(k) record lists Aidoc Medical , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BriefCase-Triage: CARE Multi-triage CT Body?

The FDA product code for BriefCase-Triage: CARE Multi-triage CT Body is QAS.

其他以 Aidoc Medical , Ltd. 為申請人之記錄

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

K261317簡易病例分類 K253578簡易包-分類：CARE多分類CT用於氣胸；心包積液；大動脈瘤；肩關節骨折或脫位設備 K251195簡易病例分類 K253265簡易病例分類 K251406簡易病例分類 K250248簡易病例分類

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相關器械（代碼：QAS）

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

K260906a2z-Abdo-分類評估A2z Radiology Ai, Inc.K261085快速血管阻塞（快速VO）iSchemaview K260729血管輔助阻斷分類（VAOT）（v1.0）GuideAI Health K261317簡易病例分類Aidoc Medical , Ltd.K253163EFAI ERSUITE CT 腹膜炎評估系統 (APPEN-CT-100)Ever Fortune.Ai, Co., Ltd.K252421JLK-NCCTJLK, Inc.

官方來源

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